Comparative study of the quality and efficacy of originator and generic albendazole for mass treatment of soil-transmitted nematode infections in Nepal.

Abstract

The quality and efficacy of two locally manufactured generic albendazole (ABZ) products (Curex and Royal Drug) used for deworming children in Nepal since 1999 were tested against the originator product (GlaxoSmithKline (GSK)). The study included disintegration and dissolution testing according to the Indian Pharmacopoeia (IP) and the United States Pharmacopeia (USP), respectively, as well as a randomised controlled clinical trial comparing cure rates (CR) and egg reduction rates (ERR) for Ascaris lumbricoides, Trichuris trichiura and hookworm infections. Stool samples from 1277 children were examined before and 21 days after treatment. For A. lumbricoides, GSK (97.0%) and Royal Drug (95.0%) ABZ achieved significantly higher CRs than Curex ABZ (82.6%); however, all products achieved ERRs >90%. For T. trichiura, Curex ABZ showed significantly lower ERRs (63.2%). For hookworms, GSK ABZ performed significantly better (CR 74.3%, ERR 87.1%) than Royal Drug ABZ (CR 53.3%, ERR 80.8%) and Curex ABZ (CR 50.7%, ERR 73.1%). Only the GSK product passed both disintegration and dissolution tests according to the IP and USP. Both generic products failed the dissolution tests. Curex ABZ showed poor disintegration. Despite its lower efficacy, the cheaper Curex product achieved good results in controlling morbidity due to soil-transmitted helminth infections. This study shows that the cost effectiveness of drugs used in mass deworming campaigns should not be inferred on the basis of a single quality testing parameter.

• Authors: Marco Albonico, Pragya Mathema, Antonio Montresor, Balkrishna Khakurel, Valerio Reggi, Sharada Pandey, Lorenzo Savioli
• Journal: Transactions of the Royal Society of Tropical Medicine and Hygiene (Trans R Soc Trop Med Hyg) Vol. 101 Issue 5 Pg. 454-60 (May 2007) ISSN: 0035-9203 [Print] England
• PMID: 17129592 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anthelmintics
• Drugs, Generic
• Soil
• Albendazole

Topics

• Adolescent
• Albendazole (standards, therapeutic use)
• Anthelmintics (standards, therapeutic use)
• Child
• Community Health Services
• Drug Stability
• Drugs, Generic (standards, therapeutic use)
• Feces (parasitology)
• Female
• Humans
• Laboratories (standards)
• Male
• Nematode Infections (drug therapy, transmission)
• Nepal
• Parasite Egg Count
• Quality Control
• Single-Blind Method
• Soil (parasitology)
• Treatment Outcome